CompletedPhase 4

Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting

Austria, Germany100 participantsStarted 2009-09-01

Plain-language summary

This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine. The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 50
✓. 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
✓. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
✓. All target VCFs are between Th5 and L5
✓. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
✓. No major surgery to the spine planned for at least 1 month following enrollment
✓. Pre-treatment back pain by numerical rating scale (NRS) score \>= 4 (0-10 scale)
✓. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion criteria

✕. VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
✕. Fracture due to high-energy trauma
✕. Suspected OR proven cancer inside index vertebral body.
✕. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)

What they're measuring

Increase and maintenance of the vertebral body height

Timeframe: 12 months

Visual analog scale (VAS) for back pain

Timeframe: 12 months

Adverse events

Timeframe: 12 months

Trial details

NCT IDNCT01847898

SponsorSynthes GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-31

View on ClinicalTrials.gov More Vertebral Body Fractures trials

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 50
✓. 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
✓. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
✓. All target VCFs are between Th5 and L5
✓. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
✓. No major surgery to the spine planned for at least 1 month following enrollment
✓. Pre-treatment back pain by numerical rating scale (NRS) score \>= 4 (0-10 scale)
✓. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion criteria

✕. VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
✕. Fracture due to high-energy trauma
✕. Suspected OR proven cancer inside index vertebral body.
✕. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)